Vaccine Development and Manufacturing

Following the recommendation of an independent vaccine panel, FDA is advising vaccine manufacturers to include an Omicron BA.4 and BA.5 component to their booster doses.

The Sanofi-GSK vaccine is the first candidate to demonstrate efficacy in a placebo-controlled trial with a high-Omicron environment.

The agency will review laboratory study and CMC data on the bivalent vaccine that targets two strains of the SARS-CoV-2 virus.

Batavia Biosciences is expanding its headquarters and R&D capabilities in its Netherlands facility.

The expansion at Seqirus’ Holly Springs, N.C., manufacturing facility will support the formulation and fill/finish of influenza vaccines.

AstraZeneca's recombinant COVID-19 vaccine, originally invented by the University of Oxford, has been approved as a third dose booster vaccine in the EU.

Advances in therapeutic modalities and an increase in molecular complexity have led to the need for an evolution in drug delivery approaches over the years.

GeoVax has received a patent for its malaria vaccine from the US Patent and Trademark Office.

The European Investment Bank has provided €15 million to fund coronavirus research at IRBM.

ReiThera and Exothera are collaborating to develop a large-scale, low-cost-per-dose manufacturing process to deliver novel vaccines to low and middle-income countries.

IAVI and Moderna have announced a new collaboration to employ mRNA technology to meet the challenge of a range of global health issues.

Catalent has acquired the Vaccine Manufacturing Innovation Centre in Harwell, Oxford to expand its biologics capabilities across the UK and Europe.

Merck has expanded its manufacturing facility in Elkton, Va. to further increase its HPV vaccine supply.

UK government has awarded chemical producer Croda a £15.9 million grant to increase the UK’s capacity to manufacture key vaccine ingredients.

KeyPlants has shipped a first-of-its-kind vaccine manufacturing facility to Senegal in West Africa.

Pfizer’s respiratory syncytial virus vaccine candidate has received Breakthrough Therapy Designation from FDA for the prevention of RS in older adults.

NIH has launched one of the first Phase 1 clinical trials to examine mRNA technology for HIV.

Johnson & Johnson have announced a landmark agreement to enable the manufacturing and availability of its COVID-19 vaccine in Africa by an African company.

Moderna has announced that it has entered a Memorandum of Understanding with the government of the Republic of Kenya to establish its first mRNA manufacturing facility in Africa.

Evonik has increased its global supply of plant-derived cholesterol used for mRNA vaccines and gene therapies.

A consortium of nine development partners will support Biovac's expansion of its existing vaccine manufacturing plant capacity, while Biovac itself aims to raise funds to boost increased vaccine manufacturing capacity across Africa.

Under a collaboration, IDT Biologika and Exothera will conduct feasibility studies on scaling up the manufacturing process for viral vector-based vaccines.

Pfizer has received Breakthrough Therapy Designation from FDA for its RSV vaccine candidate for prevention of RSV illness in infants by active immunization of pregnant women.

The continuous, aseptic fill/finish process is finding use in vaccines and biologic drugs.

Pfizer and BioNTech receive positive opinion for COVID-19 vaccine booster in adolescents 12 through 17 years of age in the EU.